tct 2012 | miami, fl | october 24, 2012 three-year outcomes of transcatheter aortic valve...
TRANSCRIPT
![Page 1: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/1.jpg)
TCT 2012 | Miami, FL | October 24, 2012
Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) in “Inoperable” Patients With Severe Aortic Stenosis: The PARTNER Trial
Samir R. Kapadia, MD On behalf of The PARTNER Trial Investigators
![Page 2: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/2.jpg)
• Samir Kapadia – No financial disclosures
– Member of PARTNER Trial steering committee
• Murat Tuzcu– No financial disclosures
– Member of PARTNER Trial executive committee
![Page 3: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/3.jpg)
Background (1)
• Transcatheter aortic valve replacement (TAVR) is the recommended treatment for “inoperable” patients with severe aortic stenosis (AS), based upon 1-year results of The PARTNER Trial which demonstrated reduced mortality and improved quality of life.
• However, whether clinical benefit and valve performance are sustained beyond two years is unknown and longer term outcomes will importantly alter clinical practice decisions.
![Page 4: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/4.jpg)
Background (2)
![Page 5: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/5.jpg)
Objectives
• To evaluate the clinical outcomes of TAVR compared to standard therapy at 3 years in “inoperable” aortic stenosis patients.
• To assess valve hemodynamics and durability using echocardiography.
• To perform subgroup analyses to better define the impact of co-morbidities on outcomes.
![Page 6: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/6.jpg)
PARTNER Study Design
n = 358Inoperable
StandardTherapyn = 179
ASSESSMENT: Transfemoral
Access
TF TAVRn = 179
Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority)
1:1 Randomization
VS
Symptomatic Severe Aortic Stenosis
• Primary endpoint evaluated when all patients reached one year follow-up.• After primary endpoint analysis reached, patients were allowed to cross-over to TAVR.
![Page 7: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/7.jpg)
Inclusion Criteria
• Severe calcific aortic stenosis defined as echo derived valve area of < 0.8 cm2 (EOA index < 0.5 cm2/m2), and mean gradient > 40 mmHg or jet velocity > 4.0 m/s.
• NYHA functional class ≥ II
• Inoperable defined as risk of death or serious irreversible morbidity of AVR as assessed by cardiologist and two surgeons exceeding 50%.
![Page 8: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/8.jpg)
Key End-Points for 3 Year Analysis
• All cause mortality
• Cardiac mortality
• Rehospitalization
• Adverse outcomes including stroke, bleeding, renal failure, and MI
• NYHA functional class
• Days alive and out of hospital
• Echo-derived valve areas, transvalvular gradients, and paravalvular aortic regurgitation
• Mortality outcomes stratified by STS score
![Page 9: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/9.jpg)
n = 358Randomized Inoperable
n = 179TAVR
n = 179Standard Therapy
124/124 patients100% followed at 1 Yr
124/124 patients100% followed at 1 Yr
85/85 patients100% followed at 1 Yr
85/85 patients100% followed at 1 Yr
101/102 patients*99.0% followed at 2 Yr
101/102 patients*99.0% followed at 2 Yr
46/46 patients100% followed at 2 Yr
46/46 patients100% followed at 2 Yr
Study FlowInoperable Cohort
• *One TAVR patient was alive and censored prior to the window• **Two TAVR patients were alive and censored prior to the window (including the one
in the same status at 2 years); one TAVR patient withdrew between 2 and 3 years• No patients were lost to follow-up
80/82 patients**97.6% followed at 3 Yr
80/82 patients**97.6% followed at 3 Yr
19/19 patients100% followed at 3 Yr
19/19 patients100% followed at 3 Yr
Cross over 11 pts
Cross over 9 pts
![Page 10: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/10.jpg)
Statistical Method
• Primary analysis was by “intention-to-treat” (ITT).
• Clinical outcomes were analyzed by ITT with censoring of Standard Rx cross-over patients.
• Additional analysis of death was performed by following cross-over patients with their randomized trial arms.
• Event rates are given as Kaplan-Meier estimates.
• Core lab echo results are presented from the valve implant population (valve retained in position).
![Page 11: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/11.jpg)
Patient Characteristics (1)
Characteristic TAVRn = 179
Standard Rxn = 179
p value
Age – yr 83.1 ± 8.6 83.2 ± 8.3 0.95
Male sex (%) 45.8 46.9 0.92
STS Score 11.2 ± 5.8 12.1 ± 6.1 0.14
NYHA I or II (%) III or IV (%)
7.892.2
6.193.9
0.680.68
CAD (%) 67.6 74.3 0.20
Prior MI (%) 18.6 26.4 0.10
Prior CABG (%) 37.4 45.6 0.17
Prior PCI (%) 30.5 24.8 0.31
Prior BAV (%) 16.2 24.4 0.09
CVD (%) 27.4 27.5 1.00
Note: Same as previously presented at TCT 2010 and published in the NEJM manuscript.
![Page 12: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/12.jpg)
Patient Characteristics (2)
Characteristic TAVRn = 179
Standard Rxn = 179
p value
PVD (%) 30.3 25.1 0.29
COPD Any (%) O2 dependent (%)
41.321.2
52.525.7
0.040.38
Creatinine > 2 mg/dL (%) 5.6 9.6 0.23
Atrial fibrillation (%) 32.9 48.8 0.04
Perm. pacemaker (%) 22.9 19.5 0.49
Pulmonary HTN (%) 42.4 43.8 0.90
Frailty (%) 18.1 28.0 0.09
Porcelain aorta (%) 19.0 11.2 0.05
Chest wall radiation (%) 8.9 8.4 1.00
Chest wall deformity (%) 8.4 5.0 0.29
Liver disease (%) 3.4 3.4 1.00
Note: Same as previously presented at TCT 2010 and published in the NEJM manuscript.
![Page 13: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/13.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Numbers at Risk
Standard Rx 179 121 85 62 46 27 17
TAVR 179 138 124 110 101 88 70
All Cause Mortality (ITT)Crossover Patients Censored at Crossover
30.7%
50.8%
43.0%
68.0%
54.1%
80.9%
All
Cau
se M
orta
lity
(%)
Months
HR [95% CI] = 0.53 [0.41, 0.68]p (log rank) < 0.0001
20.1%
25.0%
26.8%
NNT = 5.0 pts
NNT = 4.0 pts
NNT = 3.7 pts
Standard RxTAVR
![Page 14: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/14.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Cardiovascular Mortality (ITT)Crossover Patients Censored at Crossover
20.5%
44.6%
30.7%
62.4%
41.4%
74.5%
Car
diov
ascu
lar
Mor
talit
y (%
)
Numbers at Risk
Standard Rx 179 121 85 62 46 27 17
TAVR 179 138 124 110 101 88 70
Months
HR [95% CI] = 0.41 [0.30, 0.56]p (log rank) < 0.0001
24.1%
31.7%
33.1%
NNT = 4.1 pts
NNT = 3.2 pts
NNT = 3.0 pts
Standard RxTAVR
![Page 15: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/15.jpg)
0%
20%
40%
60%
80%
100%
MonthsNumbers at Risk
Standard Rx 179 121 85 62 46 27 17
TAVR 179 138 124 110 101 88 70
0 6 12 18 24 30 36
All Cause Mortality (ITT)Landmark Analysis
30.7%
50.8%
17.8%
35.1%
19.3%
40.3%
All
Cau
se M
orta
lity
(%)
HR [95% CI] = 1.90 [1.05, 3.43]p (log rank) = 0.03
HR [95% CI] = 2.03 [1.36, 3.04]p (log rank) = 0.0005
HR [95% CI] = 0.53 [0.41, 0.68]p (log rank) < 0.0001
∆ = 20.1% ∆ = 17.3% ∆ = 21.0%NNT = 5.0 pts NNT = 5.8 pts NNT = 4.8 pts
Standard RxTAVR
![Page 16: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/16.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 360%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Repeat Hospitalization (ITT)
53.9%
27.0%
72.5%
34.9%
75.7%
42.3%
71.6%
44.1%
88.0%
56.5%
93.1%
66.3%
Numbers at Risk
Standard Rx 179 86 49 30 19 11 7 179 86 49 30 19 11 7TAVR 179 115 100 89 77 64 49 179 115 100 89 77 64 49
Months Months
Reh
ospi
taliz
atio
n (%
)
Mor
talit
y or
Reh
ospi
taliz
atio
n (%
)
Rehospitalization Mortality or Rehospitalization
Standard Rx
TAVR
33.4%
HR [95% CI] = 0.39 [0.28, 0.54]p (log rank) < 0.0001
NNT = 3.7 pts
NNT = 2.7 pts
NNT = 3.0 pts NNT = 3.6 pts
NNT = 3.2 pts
NNT = 3.7 pts37.6%
26.9%
26.8%31.5%
27.5%
HR [95% CI] = 0.46 [0.36, 0.58]p (log rank) < 0.0001
TAVR 944 [233-1096] Standard Rx 368 [147-1096] p <.0001Days Alive Out of Hospital Median [IQR]
![Page 17: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/17.jpg)
0%
20%
40%
60%
80%
100%
TAVR
179
Standard Rx
179
TAVR
173
Standard Rx
167
TAVR
173
Standard Rx
160
TAVR
165
Standard Rx
146
Dead
IV
III
II
I
NYHA Class Over Time (ITT)
Baseline 1 Year 2 Year 3 Year
p < 0.0001
N =
p = NS p < 0.0001 p < 0.0001
58.8%
91.1%
45.7%
76.9%
34.7%
59.3%
43.6% 45.3%
![Page 18: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/18.jpg)
0%
10%
20%
30%
40%
50%
0 6 12 18 24 30 36
All Stroke (ITT)
5.5%
11.2%
5.5%
13.7%
5.5%
15.7%Str
oke
(%)
Months
HR [95% CI] = 2.77 [1.24, 6.19]p (log rank) = 0.0094
∆ = 5.7%
NNT = 17.5 ptsNNT = 12.2 pts
NNT = 9.8 pts
∆ = 8.2%∆ = 10.2%
Standard RxTAVR
Numbers at Risk
TAVR 179 128 116 105 96 82 65
Standard Rx 179 118 84 62 46 27 17
![Page 19: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/19.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Numbers at Risk
Standard Rx 179 118 84 62 46 27 17
TAVR 179 128 116 105 96 82 65
Mortality or Stroke (ITT)
51.3%
35.2%
45.8%
57.5%
68.0%
80.9%
Mor
talit
y or
Str
oke
(%)
Months
HR [95% CI] = 0.60 [0.46, 0.77]p (log rank) < 0.0001
16.1%
22.2%
23.4%
NNT = 6.2 pts
NNT = 4.5 pts
NNT = 4.3 pts
Standard RxTAVR
![Page 20: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/20.jpg)
44.2
10.211.0 10.9 10.8 11.3
0.6
1.5
1.6 1.6 1.6 1.5
0
0.5
1
1.5
2
2.5
0
10
20
30
40
50
60
70
Baseline
159
30 Day
137
6 Month
96
1 Year
86
2 Year
70
3 Year
43
Mean Gradient & Valve AreaM
ean
Gra
dien
t (m
mH
g)
EOAMean Gradient
Val
ve A
rea
(cm
²)
N =
Error bars = ± 1 Std Dev
![Page 21: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/21.jpg)
0%
20%
40%
60%
80%
100%
30 Day
44
6 Month
45
1 Year
44
2 Year
45
3 Year
46
Valve Implant Patients(restricted to patients with 3 year values)
Severe
Moderate
Mild
Trace
None
Paravalvular LeakP
erce
nt o
f eva
luab
le e
chos
N =
![Page 22: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/22.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 360%
20%
40%
60%
80%
100%
0 6 12 18 24 30 360%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Mortality Stratified by STS Score (ITT)
Mor
talit
y (%
)
Months Months Months
STS: 0 - 4.9 STS: 5.0 - 14.9 STS ≥ 15
Standard Rx
TAVR
∆ = 66.8%
NNT = 1.5 pts NNT = 4.5 pts NNT = 4.8 pts
∆ = 20.8%∆ = 22.3%
Numbers at Risk
Standard Rx 12 8 7 6 5 3 0 123 86 61 44 33 19 13 43 27 17 12 8 5 4
TAVR 28 26 25 24 21 19 16 113 84 79 70 65 55 44 38 28 20 16 15 14 10
100%
33.2%
86.6%
65.8%55.2%
77.5%
![Page 23: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/23.jpg)
Non-Randomized Continued Access
Cohort B:235 Patients
Randomized PARTNER
Cohort A: 699 Patients
May 2007 – September 2009
PARTNER Secondary Analysis Pooled Cohort (ITT)
Randomized PARTNER
Cohort B: 358 Patients
2007 2008 2009
Randomized PARTNER
Cohort BRandomized Continued Access: 91 Patients
May 2007 – March 2009 March 2009 – September 2009
September 2009 –January 2012
Non-Randomized Continued Access
Cohort A:1,833 Patients
September 2009 –July 2011
![Page 24: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/24.jpg)
Primary Outcome (Composite)All Cause Mortality
![Page 25: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/25.jpg)
Conclusions (1)
• At 3 years follow-up benefits of TAVR were sustained as measured by:– All cause mortality– Cardiovascular mortality– Repeat hospitalization– Functional status
• Valve durability was demonstrated with no increase in transvalvular gradient or attrition of valve area.
• Detailed analysis of all randomized inoperable patients showed consistent results for all outcomes.
![Page 26: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/26.jpg)
Conclusions (2)
• Survival benefit of TAVR is dependent on the presence of comorbid illness.
• Without TAVR, mortality is similar irrespective of comorbid illness.
![Page 27: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/27.jpg)
Clinical Implications
• Three year data continue to support the role of TAVR as the standard-of-care for symptomatic patients with aortic stenosis who are not surgical candidates.
• These data underscore the importance of patient selection before TAVR and the need for aggressive management of illnesses after TAVR.
![Page 28: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/28.jpg)
Thank You to the Dedicated Study Teams at All PARTNER Investigational Sites
![Page 29: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/29.jpg)
![Page 30: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/30.jpg)
Backup Slides
![Page 31: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/31.jpg)
n = 358Randomized Inoperable
n = 179TAVR
n = 179Standard Therapy
124/124 patients100% followed at 1 Yr
124/124 patients100% followed at 1 Yr
85/85 patients100% followed at 1 Yr
85/85 patients100% followed at 1 Yr
101/102 patients*99.0% followed at 2 Yr
101/102 patients*99.0% followed at 2 Yr
56/56 patients100% followed at 2 Yr
56/56 patients100% followed at 2 Yr
Study FlowInoperable Cohort – Crossover Patients Followed in Standard Therapy Arm
• *One TAVR patient was alive and censored prior to the window• **Two TAVR patients were alive and censored prior to the window (including the one
in the same status at 2 years); one TAVR patient withdrew between 2 and 3 years• No patients were lost to follow-up
80/82 patients**97.6% followed at 3 Yr
80/82 patients**97.6% followed at 3 Yr
34/34 patients100% followed at 3 Yr
34/34 patients100% followed at 3 Yr
![Page 32: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/32.jpg)
Survival of Crossover Patients
1-2 yearn = 11
2-3 yearn = 9
Alive, n (%) Dead, n (%) Alive, n (%) Dead, n (%)
8 (72%) 3 (28%) 7 (77%) 2 (22%)
Crossover Follow-up (days) Crossover Follow-up (days)
522 ± 129 323 ± 248 469 ± 178 110 ± 11
• No patients crossed over after three years
![Page 33: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/33.jpg)
Survival of Crossover Patients
Crossover Patients n 30 Day MortalityEvents (%)
1 Year MortalityEvents (%)
Last Follow-Up MortalityEvents (%)
1-2 year 11 0 (0) 1 (9) 3 (27)
2-3 year 9 0 (0) 2 (22) 2 (22)
All 20 0 (0) 3 (15) 5 (20)
Follow-up of surviving patients = 497 ± 150 days
![Page 34: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/34.jpg)
0%
20%
40%
60%
80%
100%
Cardiovascular Mortality (ITT)Landmark Analysis
20.5%
44.6%
12.7%
32.1%
15.1%
32.2%
Car
diov
ascu
lar
Mor
talit
y (%
)
Numbers at Risk
Standard Rx 179 121 85 62 46 27 17
TAVR 179 138 124 110 101 88 70
HR [95% CI] = 0.41 [0.30, 0.56]p (log rank) < 0.0001
HR [95% CI] = 2.48 [1.56, 3.95]p (log rank) < 0.0001
HR [95% CI] = 2.09 [1.05, 4.16]p (log rank) = 0.0314
∆ = 24.1% ∆ = 19.4% ∆ = 17.1%
NNT = 4.1 pts NNT = 5.2 pts NNT = 5.8 pts
0 6 12 18 24 30 36
Months
Standard RxTAVR
![Page 35: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/35.jpg)
0%
20%
40%
60%
80%
100%
TAVR
179
Standard Rx
179
TAVR
118
Standard Rx
79
TAVR
96
Standard Rx
41
TAVR
69
Standard Rx
14
IV
III
II
I
NYHA Class Over Time (ITT)Survivors
Baseline 1 Year 2 Year 3 Year
N =
29.0%
50.0%
17.7%
56.1%
23.7%
60.8%
92.2% 93.9%
p = NSp = NS p < 0.0001 p < 0.0001
![Page 36: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/36.jpg)
Adverse EventsBetween 2 and 3 years (ITT)
3 Yearn = 179
2-3 Yearn = 179
Outcome TAVR Standard Rx TAVR Standard Rx
Myocardial infarction
All, % (n) 4.0 (4) 2.5 (2) 2.4 (2) 0 (0)
Acute kidney injury
Renal failure (CEC), % (n) 3.2 (5) 11.1 (10) 0 (0) 3.7 (1)
Bleeding – major, % (n) 32.0 (51) 32.9 (28) 3.4 (3) 13.0 (3)
Cardiac re-intervention
BAV, % (n) 3.8 (5) 85.3 (140) 1.0 (1) 4.7 (2)
TAVR, % (n) 1.7 (3) 4.5 (4) 0 (0) 0 (0)
AVR, % (n) 0.9 (1) 8.9 (11) 0 (0) 0 (0)
Endocarditis, % (n) 2.3 (3) 0.8 (0) 0 (0) 0 (0)
New pacemaker, % (n) 7.6 (11) 8.6 (14) 1.2 (1) 0 (0)
![Page 37: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/37.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Numbers at Risk
Mild-Severe 101 78 70 62 56 48 35
None-Trace 64 51 47 43 41 37 29
Mortality Stratified by Paravalvular Leak Valve Implant Patients
30.7%
26.6%
44.6%
34.4%
56.0%
45.6%
Months
Mor
talit
y (%
)
HR [95% CI] = 1.15 [0.76, 1.74]p (log rank) = 0.5114
∆ = 10.4%
NNT = 24.4 pts
NNT = 9.8 pts
NNT = 9.6 pts
∆ = 4.1%
∆ = 10.2%
Mild-SevereNone-Trace
![Page 38: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/38.jpg)
Echo Analysis PV Leak Changes 30 Days Compared to 3 Years
16.0% Progressed31.8% Improved 52.3% Unchanged
3 Year
30 Day None Trace Mild Moderate
None 7 3 0 0
Trace 5 5 2 0
Mild 5 1 11 2
Moderate 0 1 2 0
Of the 44 patients alive with data at both 30 days and 3 years:
Patients With Data at Both Time Points
![Page 39: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/39.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Numbers at Risk
> 15 38 28 20 16 15 14 10 5 - 15 113 84 79 70 65 55 44 < 5 28 26 25 24 21 19 16
TAVR Mortality Stratified by STS Score (ITT)
10.7%
47.4%
30.1%
21.6%
60.5%
42.5%
33.2%
65.8%
55.2%
Mor
talit
y (%
)
5 - 15> 15
< 5
Months
p (log rank) = 0.0503
![Page 40: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/40.jpg)
Patient Characteristics (1)Pooled
Characteristic TAVRn = 229
Standard Rxn = 220
p value
Age – yr (SD) 83.2 (8.5) 83.0 (8.5) 0.8
Male sex (%) 48.5 47.7 0.9
STS Score (SD) 12.2 (5.4) 11.4 (6.0) 0.1
NYHA III or IV (%) 94.3 92.7 0.6
CAD (%) 73.8 65.9 0.08
Prior MI (%) 28.4 22.3 0.1
Prior CABG (%) 42.4 31.8 0.02
Prior PCI (%) 22.7 25.9 0.4
Prior BAV (%) 21.4 13.6 0.04
CVD (%) 25.8 26.8 0.6
![Page 41: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/41.jpg)
Patient Characteristics (2)Pooled
Characteristic TAVRn = 229
Standard Rxn = 220
p value
PVD (%) 24.9 30.0 0.2
COPD Any (%) O2 dependent (%)
72.924.7
64.322.0
0.10.8
Creatinine > 2 mg/dL (%) 8.8 5.5 0.2
Atrial fibrillation (%) 26.6 20.8 0.2
Perm. pacemaker (%) 19.7 20.5 0.9
Pulmonary HTN (%) 50.7 47.7 0.6
Frailty (%) 25.6 17.8 0.1
Porcelain aorta (%) 11.8 18.6 0.049
Chest wall radiation (%) 7.9 7.7 1.0
Chest wall deformity (%) 6.1 7.7 0.6
Liver disease (%) 3.5 5.0 0.4
![Page 42: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/42.jpg)
Primary Outcome (Composite)Functional Status
![Page 43: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/43.jpg)
Primary Outcome (Composite)Mean Gradient & AVA
![Page 44: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/44.jpg)
Univariate and Multivariate Predictors of Mortality after TAVR
Univariate Predictors
Hazard Ratio p value
BMI > 26 0.58 (0.39 – 0.86) 0.007
Peripheral Vascular Disease 1.67 (1.13 – 2.47) 0.01
Oxygen dependent COPD 1.62 (1.05 -2.49) 0.03
History of Stroke or TIA 3.19 (1.28 – 7.92) 0.01
History of CABG 0.64 (0.42 – 0.98) 0.04
Multivariate Predictors
Hazard Ratio p value
BMI > 26 0.47 (0.31 – 0.70) 0.02
Peripheral Vascular Disease 1.59 (1.07 – 2.38) 0.02
Oxygen dependent COPD 1.83 (1.17 – 2.85) 0.008
Moderate or Severe MR 0.56 (0.33 – 0.94) 0.03
![Page 45: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/45.jpg)
Pooled Randomized
![Page 46: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/46.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Numbers at Risk
Standard Rx 229 163 118 77 56 33 17
TAVR 220 169 151 133 117 103 70
All Cause Mortality (ITT)Pooled RandomizedCrossover Patients Censored at Crossover
31.4%
45.5%
44.8%
64.3%
54.9%
78.0%
All
Cau
se M
orta
lity
(%)
Months
HR [95% CI] = 0.60 [0.47, 0.76]p (log rank) < 0.0001
14.1%
19.5%
23.1%
NNT = 7.1 pts
NNT = 5.1 pts
NNT = 4.3 pts
Standard RxTAVR
![Page 47: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/47.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Cardiovascular Mortality (ITT)Pooled RandomizedCrossover Patients Censored at Crossover
21.0%
38.4%
31.2%
56.9%
41.4%
70.2%
Car
diov
ascu
lar
Mor
talit
y (%
)
Numbers at Risk
Standard Rx 229 163 118 77 56 33 17
TAVR 220 169 151 133 117 103 70
Months
HR [95% CI] = 0.47 [0.36, 0.63]p (log rank) < 0.0001
17.4%
25.7%
28.8%
NNT = 5.7 pts
NNT = 3.9 pts
NNT = 3.5 pts
Standard RxTAVR
![Page 48: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/48.jpg)
0%
20%
40%
60%
80%
100%
All Cause Mortality (ITT)Pooled Randomized – Landmark Analysis
31.4%
45.5%
19.6%
34.4%
18.3%
38.5%
All
Cau
se M
orta
lity
(%)
MonthsNumbers at Risk
Standard Rx 229 163 118 77 56 33 17
TAVR 220 169 151 133 117 103 70
HR [95% CI] = 1.94 [1.09, 3.45]p (log rank) = 0.0223
HR [95% CI] = 1.94 [1.33, 2.83]p (log rank) = 0.0004
HR [95% CI] = 0.60 [0.47, 0.76]p (log rank) < 0.0001
∆ = 14.1% ∆ = 14.8% ∆ = 20.2%
NNT = 7.1 pts NNT = 6.8 pts NNT = 5.0 pts
Standard RxTAVR
0 6 12 18 24 30 36
![Page 49: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/49.jpg)
0%
20%
40%
60%
80%
100%
Cardiovascular Mortality (ITT)Pooled Randomized – Landmark Analysis
21.0%
38.4%
12.9%
30.1%
14.8%
30.9%
Car
diov
ascu
lar
Mor
talit
y (%
)
MonthsNumbers at Risk
Standard Rx 229 163 118 77 56 33 17
TAVR 220 169 151 133 117 103 70
∆ = 17.4% ∆ = 17.2% ∆ = 16.1%
NNT = 5.7 pts NNT = 5.8 pts NNT = 6.2 pts
0 6 12 18 24 30 36
HR [95% CI] = 0.47 [0.36, 0.63]p (log rank) < 0.0001
HR [95% CI] = 2.44 [1.57, 3.78]p (log rank) < 0.0001
HR [95% CI] = 2.13 [1.09, 4.16]p (log rank) = 0.0229
Standard RxTAVR
![Page 50: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/50.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 360%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Repeat Hospitalization (ITT)Pooled Randomized
Numbers at Risk
Standard Rx 229 120 74 43 26 14 7 229 120 74 43 26 14 7
TAVR 220 142 122 106 87 73 49 220 142 122 106 87 73 49
47.4%
26.4%
66.5%
35.0%
71.4%
42.4%
65.4%
44.6%
83.8%
58.5%
90.6%
67.5%
HR [95% CI] = 0.45 [0.33, 0.61]p (log rank) < 0.0001
29.0%
NNT = 4.8 pts
NNT = 3.2 pts
NNT = 3.4 pts NNT = 4.8 pts
NNT = 4.0 pts
NNT = 4.3 pts31.5%
21.0%
23.1%
25.3%
20.8%
HR [95% CI] = 0.54 [0.44, 0.68]p (log rank) < 0.0001
Rehospitalization Mortality or Rehospitalization
Reh
ospi
taliz
atio
n (%
)
Mor
talit
y or
Reh
ospi
taliz
atio
n (%
)
Months Months
Standard Rx
TAVR
![Page 51: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/51.jpg)
0%
20%
40%
60%
80%
100%
TAVR
220
Standard Rx
229
TAVR
214
Standard Rx
213
TAVR
209
Standard Rx
187
TAVR
201
Standard Rx
169
Dead
IV
III
II
I
NYHA Class Over Time (ITT)Pooled Randomized
Baseline 1 Year 2 Year 3 Year
p < 0.0001p = NS p < 0.0001 p < 0.0001
60.2%
90.5%
47.9%
75.9%
35.1%
54.9%
44.1% 46.7%
N =
![Page 52: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/52.jpg)
0%
20%
40%
60%
80%
100%
TAVR
220
StandardRx
229
TAVR
145
Standard Rx
113
TAVR
111
Standard Rx
49
TAVR
81
Standard Rx
17
IV
III
II
I
NYHA Class Over Time (ITT)Pooled Randomized (Survivors)
Baseline 1 Year 2 Year 3 Year
25.9%
41.2%
18.0%
53.1%
23.4%
61.9%
92.7% 94.3%
p = NSp = NS
N =
p < 0.0001 p < 0.0001
![Page 53: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/53.jpg)
0%
10%
20%
30%
40%
50%
0 6 12 18 24 30 36
All Stroke (ITT)Pooled Randomized
Numbers at Risk
Standard Rx 229 160 117 77 56 33 17
TAVR 220 158 142 127 112 97 65
4.2%
10.5%
4.2%
12.7%
4.2%
14.4%Str
oke
(%)
Months
HR [95% CI] = 3.33 [1.51, 7.35]p (log rank) = 0.0016
∆ = 6.3%
NNT = 15.9 ptsNNT = 11.8 pts
NNT = 9.8 pts
∆ = 8.5% ∆ = 10.2%
Standard RxTAVR
![Page 54: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/54.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Mortality or Stroke (ITT)Pooled Randomized
Numbers at Risk
Standard Rx 229 160 117 77 56 33 17
TAVR 220 158 142 127 112 97 65
45.9%
35.5%
47.1%
57.8%
64.2%
78.0%
Mor
talit
y or
Str
oke
(%)
HR [95% CI] = 0.67 [0.53, 0.85]p (log rank) = 0.0008
10.4%
17.1%
20.2%
NNT = 9.6 pts
NNT = 5.8 pts
NNT = 5.0 pts
Standard RxTAVR
Months
![Page 55: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/55.jpg)
43.6
10.210.7 10.7 10.9 11.6
0.6
1.6
1.6 1.6 1.5 1.5
0
0.5
1
1.5
2
2.5
0
10
20
30
40
50
60
70
Baseline
196
30 Day
168
6 Month
120
1 Year
107
2 Year
82
3 Year
49
Mean Gradient & Valve AreaPooled Randomized
Mea
n G
radi
ent (
mm
Hg)
EOAMean Gradient
Val
ve A
rea
(cm
²)
N =
Error bars = ± 1 Std Dev
![Page 56: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/56.jpg)
0%
20%
40%
60%
80%
100%
30 Day
50
6 Month
50
1 Year
50
2 Year
51
3 Year
52
Valve Implant Patients(restricted to patients with 3 year values)
Severe
Moderate
Mild
Trace
None
Paravalvular LeakPooled Randomized
Per
cent
of e
valu
able
ech
os
N =
![Page 57: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/57.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Mortality Stratified by Paravalvular Leak (ITT)Pooled Randomized – Valve Implant Patients
Numbers at Risk
Mild-Severe 123 95 83 72 62 54 35
None-Trace 81 65 61 55 51 46 29
32.5%
24.7%
48.1%
33.6%
59.0%
43.0%
Months
Mor
talit
y (%
)
HR [95% CI] = 1.32 [0.90, 1.94]p (log rank) = 0.1483
∆ = 16.0%
NNT = 12.8 pts
NNT = 6.9 pts
NNT = 6.3 pts
∆ = 7.8%
∆ = 14.5%
Mild-SevereNone-Trace
![Page 58: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/58.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Mortality Stratified by Paravalvular Leak (ITT)Pooled Randomized – Valve Implant Patients
Numbers at Risk
Mod.-Severe 33 25 22 20 15 14 9Mild 90 70 61 52 47 40 26None-Trace 81 65 61 55 51 46 29
24.7%
33.3%
32.2%
33.6%
47.8%
49.5%
43.0%
60.4%
58.7%
Mor
talit
y (%
)
Months
HR [95% CI] = 1.18 [0.92, 1.51]p (log rank) = 0.3517
None-TraceMildModerate-Severe
![Page 59: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/59.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Mortality Stratified by STS Score (ITT)Pooled Randomized
Numbers at Risk
> 15 47 33 25 20 17 16 10 5 - 15 141 106 97 85 77 66 44 < 5 32 30 29 28 23 21 16
9.4%
46.8%
31.2%25.4%
63.8%
42.8%
35.9%
68.1%
54.8%
Mor
talit
y (%
)
Months
p (log rank) = 0.01685 - 15> 15
< 5
![Page 60: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/60.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 360%
20%
40%
60%
80%
100%
0 6 12 18 24 30 360%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Mortality Stratified by STS Score (ITT)Pooled Randomized
Mor
talit
y (%
)
Months Months Months
STS: 0 - 4.9 STS: 5.0 - 14.9 STS ≥ 15
∆ = 64.1%
NNT = 1.6 pts NNT = 5.1 pts NNT = 6.7 pts
∆ = 15.0%∆ = 19.6%
Numbers at Risk
Standard Rx 16 11 9 6 5 3 0 154 113 84 56 41 24 13 58 39 25 15 10 6 4
TAVR 32 30 29 28 23 21 16 141 106 97 85 77 66 44 47 33 25 20 17 16 10
100%
35.9%
83.1%
68.1%54.8%
74.4%
Standard Rx
TAVR
![Page 61: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/61.jpg)
Stroke – Between year 2-3
ITT arm Age Days post randomization Description Comorbidity Procedure
related*Device related* Comments
TAVR 97 879 Ischemic Blood stream infection, Right carotid stenosis (80%)
No No Cerebellar infarct; Linear echodensity on mitral valve, Ao valve: Mild AI
TAVR 87 837 Acute infarct with surrounding intraparenchymal bleed
Atrial Fibrillation not on warfarin
No No Cerebellar infarct/ hemorrhage; Ao valve: Ok
*CEC adjudicated
![Page 62: TCT 2012 | Miami, FL | October 24, 2012 Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) inInoperable Patients With Severe Aortic Stenosis:](https://reader036.vdocuments.mx/reader036/viewer/2022062620/5519ca15550346047c8b4984/html5/thumbnails/62.jpg)
0%
20%
40%
60%
80%
100%
0 6 12 18 24 30 36
Numbers at Risk
Mild 78 61 54 47 43 36 26Mod.-Severe 23 17 16 15 13 12 9None-Trace 64 51 47 43 41 37 29
Mortality Stratified by Paravalvular LeakValve Implant Patients
26.6%
30.8%
30.4%
34.4%
43.5%
44.9%
45.6%
55.7%
57.0%
None-TraceModerate-SevereMild
Mor
talit
y (%
)
Months
HR [95% CI] = 1.09 [0.82, 1.45]p (log rank) = 0.8059